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Senior Initiation Clinical Research Associate - FSP

extra holidays - extra parental leave - fully flexible
Remote: 
Full Remote
Contract: 
Full time
Experience: 
Mid-level (2-5 years)
Work from: 
Argentina

Offer summary

Qualifications:

Bachelor's degree, 3 years in document management.

Key responsabilities:

  • Ensure completeness of Site Essential Document Packages
  • Track document translations and approval processes
Parexel logo
Parexel XLarge http://www.parexel.com
10001 Employees
About Parexel
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.
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Job description

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Parexel FSP is hiring two Senior Initiation Clinical Research Associates. Candidates could be based in Mexico, Argentina or Brazil. The position will be remote.

The Senior Initiation Clinical Research Associate will be responsible for ensuring the completeness of Site Essential Document Packages as well as the Site Regulatory Packages (SRP) required to achieve site initiation and activation status.  This also includes the renewal of critical essential documents in the event of protocol amendments introduced during the Final Approved Protocol to Last Patient, First Visit. Areas of additional responsibility include the tracking of document translations requirements, site SRP reviews and approvals, and required training activities.  
Will ensure the clinical study insurance documents are current and filed in the electronic Trial Master File (TMF) from the beginning of the study until study completion in compliance with SOPs and guidance.
Introduces specialized industry-leading and/or emerging concepts to develop innovative business solutions. Serves as an advisor, mentor, internal consultant, and/or helps drive new initiatives

Additionally, may be responsible for planning and delivery of European Union Clinical Trials Directive/Regulation (EUCTD/R) reporting according to the Part II requirements outlined by the European Medicines Agency (EMA) via the Clinical Trial Information System (CTIS). Coordination with Regulatory Affairs, Clinical Trial Management and Clinical Transparency will be core to the role.

Additionally, may serve as the primary contact for acquiring insurance documents on behalf of the clinical study team.  May serve as the main liaison between the sponsor/CRO and the insurance broker/carrier.  The Associate Manager Clinical Documentation – May ensure the clinical study insurance documents are current and filed in the electronic Trial Master File (TMF) from the beginning of the study until study completion in compliance with SOPs and guidance.

Required experience:
A bachelor's degree and 3 years in essential or regulatory document management in Pharmaceutical /CRO industry, understanding of clinical study start up requirements and working knowledge of relevant documentation.  

Required profile

Experience

Level of experience: Mid-level (2-5 years)
Spoken language(s):
English
Check out the description to know which languages are mandatory.
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